STAAR Surgical® Company Career Opportunities
Thank you for visiting STAAR Surgical Company's employment opportunities section. Our goal is to hire the best and brightest employees and provide them with an exciting and dynamic place to work.
After reviewing the current STAAR Surgical Company job openings (including the descriptions and required qualifications) and the summary of benefits offered by STAAR Surgical Company, please submit your resume to our Human Resources department for the positions that interest you. In your cover letter, please include the job for which you are applying. You may send your resume and cover letter to STAAR Surgical Company either by email to pnguyen@staar.com or by fax to (616) 358-9470. (If you choose to fax your information, please include "ATTN: Human Resources" on your cover sheet.) You will be contacted by a representative of our Human Resources department to schedule an interview if you are being considered for a position.
Current STAAR Surgical Company Job Openings
The current job openings at STAAR Surgical Company include:
Manager of Regulatory Affairs – Manager regulatory affairs team activities to ensure timely submission of new applications and renewals of product approvals worldwide – including technical files and design dossiers for CE marking.
Post-Market Surveillance Manager – Direct the timing of regulatory submissions related to post-market surveillance (MDR, baseline supplement report, annual report, etc.) to FDA to ensure regulatory compliance.
Senior Accountant – Assist with month-end close; prepare and coordinate all entries required to generate accurate monthly financial statements in accordance with GAAP.
Customer Service Representative – Answer incoming telephone calls and assist callers with orders, return requests, equipment service requests, complaints and inquiries.
Refractive Sales Manager – Manager regulatory affairs team activities to ensure timely submission of new applications and renewals of product approvals worldwide – including technical files and design dossiers for CE marking.
Practice Development Manager – Implement the practice development program for the Visian ICL.
For more information on an available STAAR Surgical Company job opening, please click on the above title of the position. STAAR Surgical Company is an equal opportunity employer. AA/EOE/M/F/D/V
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STAAR Surgical Company Benefits Summary
STAAR Surgical Company offers a comprehensive benefits package to our regular employees, including medical, dental, vision, long-term disability, life insurance, and paid vacation. Additionally, we offer a 125 c plan and a 401(k) plan which includes an employer match.
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Job Descriptions and Requirements for Current Openings
Below are expanded job descriptions, including job responsibilities and position requirements for the positions currently open at STAAR Surgical Company.
Manager of Regulatory Affairs
Main Job Responsibilities and Functions
- Manage regulatory affairs team activities to ensure timely submission of new applications and renewals for product approvals worldwide - including technical files and design dossiers for CE marking
- Manage regulatory affairs team members performance, reviews and development/training plans.
- Create an environment that ensures ongoing compliance yet enables team members to think outside the box. Mentor and monitor team members.
- Liaise with necessary regulatory agencies including Notified Body, FDA and other governmental agencies.
- Prepare and maintain 510(k)s, letters/justifications to file, Investigational Device Exemption (IDE), Pre-Market Approval (PMA) Applications, PMA supplements and annual reports for both IDE and PMA as needed for Class I, II and III medical devices.
- Prepare outline budgets for the regulatory activities and manage to activities to plan.
- Represent and arrange for others in the team to represent regulatory affairs and provide teams with respective regulatory pathways/plans/requirementson product development teams, including design control, FMEA, design and process validation, and associated documentation including written regulatory assessments for inclusion into the Design History Files.
- Review Notice of Document Changes (NDCs), Engineering Change Orders, and labeling, including assessments of regulatory impact.
- Manage the team to systematically maintain regulatory documentation, registrations and device listings and associated paperwork and electronic files.
- Review and interpret regulatory rules and ensure that they are communicated through company policies and procedures.
- Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.
- Participate in compliance activities that relate to the department and the company as a whole.
- Write/revise departmental SOPs as required.
- Perform additional duties as assigned by VP QA/RA.
Educational Qualifications
- Bachelor of Science degree in a scientific related field.
Professional Experience
- Minimum 5 years experience in Regulatory Affairs or related equivalent experience in the medical device industry required together with direct hands-on experience with implantable devices or ophthalmic devices Class 2 and above.
- Class III medical device experience preferred.
- Experience in ophthalmology desired.
Skills
- Ability to build and lead a team through setting the role model
- Ability to analyze complex situations and distill this into clear, communicable steps.
- Thorough understanding of FDA and international regulations.
- Strong working knowledge of medical devices regulations and terminologies.
- Excellent written and oral communication, and technical writing and editing skills.
- Ability to write clear, understandable technical documentation.
- Skilled at analyzing and summarizing data.
- Proficient with Microsoft Office.
- Ability to manage and prioritize multiple projects.
- Ability to delegate work by giving written and verbal directions to team members.
- Ability to work independently with minimal supervision.
- Extreme attention to detail.
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Post-Market Surveillance Manager
Main Job Responsibilities and Functions
- Direct the timing of regulatory submissions related to post-market surveillance (MDR, baseline supplement report, annual report, etc.) to FDA to ensure regulatory compliance.
- Participate in the creation, review and revision of department policies and standard operating procedures (SOPs).
- Hire, train, develop and manage staff to meet requirements stipulated in Company SOPs and the Code of Federal Regulations (CFR).
- Provide information and training around basic ophthalmic anatomy, physiology and surgery, including, but not limited to interpretations, complications, and interventions.
- Perform trending analysis of relevant complaint data at the end of every fiscal month.
- Head the Device Safety Committee and verify that data submitted is both accurate and adequate.
- Schedule meetings and ensure that everyone concerned is notified.
- Gather data and prepare presentation.
- Write and organize the minutes of the meeting.
- Send accurate current trending analysis and relevant complaint data, as well as minutes and agenda of previous device safety meeting to concerned individual, in advance, for review.
- Take full ownership of significant complaint files that require rapid or extraordinary review, investigation or corrective/preventive action (CAPA).
- Initiate CAPA and perform necessary investigations for the rapid determination of the root cause and provide proper implementation of procedures generated from the results of the investigation.
- Achieve successful FDA audits around complaint handling.
- Perform additional duties as assigned by V.P. of RA/QA
Educational Qualifications
- B.S. degree in a scientific field required.
Professional Experience
- Minimum two years experience in medical related industry.
- Minimum one year direct ophthalmic clinical experience.
Skills
- Good understanding of basic eye anatomy, surgical procedures, post-op complications, and medical terminology.
- Excellent oral and verbal communication skills; ability to communicate with surgical staff.
- Capable of performing basic statistical and trend analysis.
- Working knowledge of Microsoft office.
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Senior Accountant
Main Job Responsibilities and Functions
- Assist with month-end close; prepare and coordinate all entries required to generate accurate monthly financial statements in accordance with GAAP.
- Analyze, reconcile and research general ledger accounts; prepare bank reconciliations.
- Circuit Tree accounting and reporting.
- Perform daily bank reporting.
- Coordinate, prepare and maintain consolidated annual budgets.
- Maintain Hyperion and provide monthly reports to responsible manager.
- Assist outside auditors during quarterly review and annual audit process.
- Assist in preparation of periodic SEC filing.
- Assist in the enhancement and implementation of systems, processes and procedures.
- Manage all aspects of fixed asset accounting, including maintenance of fixed asset sub-ledger, verification of capital expense authorizations, propriety of accounting, and periodic fixed asset physical inventories (annual).
- Investigate Income, Property and Sales and Use Tax notices and coordinate return preparation with outside tax consultants.
- Daily update of Canadian exchange rates in InfoFlo.
- Participation in the Sarbanes-Oxley task force.
- Special projects and other duties as assigned by General Accounting Manager, Controller, or CFO.
Educational Qualifications
- Bachelor's degree in Accounting or related field required.
- CPA certification desirable but not required.
Professional Experience
- Minimum three years in a financial setting (preferably in a manufacturing environment).
- Strong exposure to all facets of accounting, including month end closing, accounts payable, fixed assets and payroll processing.
Skills
- Excellent verbal and written communication skills.
- Excellent analytical, prioritization, decision-making, and management skills.
- Excellent PC skills.
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Customer Service Representative
Main Job Responsibilities and Functions
- Answer incoming telephone calls and assist callers with orders, return requests, equipment service requests, complaints and inquiries.
- Customer follow-up.
- Process fax and telephone orders and transactions.
- Process Return Goods Authorizations (RGA).
- Research and resolve problems.
- Customer master maintenance and consignment warehouse maintenance. Consignment inventory management.
- Monthly and weekly notifications to, and follow-up with, customers regarding unbilled product, expired product and product designated for return.
- Process consignment physical inventories and participate in the process of consignment inventory control.
- Process price requests.
- Maintain the file room and fax/copier/printer room.
- Telemarketing and telesales.
- Work toward achieving Company goals; participate in the sales process through customer and sales contacts.
- Other projects and duties as assigned by Customer Service Manager.
Educational Qualifications
- High School Graduate or equivalent.
Professional Experience
- Minimum one year customer service experience.
- Data entry and telephone experience.
Skills
- Type 45 wpm or better.
- Ten-key by touch.
- Good verbal and written communication skills.
- PC word processing.
- Flexible; adjusts quickly to changes.
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Refractive Sales Manager
Main Job Responsibilities and Functions
- Responsible for the direct sales of STAAR Surgical's Refractive surgical products and services.
- Using consultative selling skills, build relationships with refractive surgeons and manage a territory to meet or exceed ICL sales objectives set by sales management.
- Work with Practice Development Specialists to coordinate, develop and implement practice building initiatives in qualified physician practices.
- Actively participate in sales team activities.
- Communicate in a timely and responsible manner with sales and marketing management, customers, and customer service.
- Target and develop new Visian ICL surgeons in the territory.
- Establish relationships with key decision makers in ASC's, surgical suites and hospital owned ASC's to drive economies of scale in facility fees.
- Present P&L comparisons on ICL vs. Lasik to target Visian ICL surgeons.
- Utilize all marketing tools provided by company to grow ICL sales.
Educational Qualifications
- Bachelors of Science/Arts degree required
Professional Experience
- 7-10 years refractive sales experience
- Knowledge of medical devices is highly desirable; ophthalmology background strongly preferred
- History of outstanding achievements and proven sales skills
- Proven track record of consistently exceeding goals and being in the top 10% of the sales force is also desired
Skills
- Excellent leadership, interpersonal, analytical, verbal and written communication skills
- Strong work ethic and customer focus demonstrated by ability to prioritize and manage multiple tasks
- Ability to manage extensive travel, both air and land
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Practice Development Manager
Main Job Responsibilities and Functions
- Implement the practice development program for the Visian ICL including, but not limited to:
- Practice assessment tools for identifying areas of need/improvement within a particular clinic setting
- Detailed set of instructions for integrating the Visian ICL into the practice including phone scripts, counselor training materials, patient seminar assistance, OD referral guidance and implementation of company sponsored marketing materials
- Instructions for local media choice and placement
- Assist with developing an on-going practice development seminar to provide practices with current updates on Visian ICL information. These seminars may be held quarterly at different locations within the country, or in conjunction with National meetings, or both as necessary.
- Present staff training to practices and assist in growing their ICL business.
- Travel to various practice settings to perform on-site evaluations and assistance as necessary.
- Work directly with application specialists, sale representatives and physicians to leverage business opportunity and increase revenues by adding value to practice setting.
- Report weekly progress and monthly overall updates to supervisor
- Participate in team meetings, conference calls and strategies as needed, to develop new tools for Practice Development
- Attend corporate meetings and conferences, as directed.
- Any other responsibilities deemed appropriate by supervisor
Educational Qualifications
- Bachelors of Science/Arts degree in any field of study preferred or equivalent work experience required
Professional Experience
- Five (5) to ten (10) years medical device experience (sales or marketing) with at least five (5) years of refractive practice development experience.
- Expert in practice settings.
Skills
- Computer literate with proficient skills in Microsoft Excel, PowerPoint, Word and Project
- Excellent communication skills and ability to work closely with senior level management
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For more information on employment information or company information, contact STAAR Surgical Company today.
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